Akebia

Vafseo® approved by the U.S. FDA for the treatment of anemia due to chronic kidney disease in dialysis-dependent adult patients

Retrieved on: 
Thursday, March 28, 2024
CSL Vifor, Thrombosis, Myocardial infarction, Akebia, CKD, Patient, Tablet, Public, Stroke, Death, Therapy, Nephrology, Safety, Chronic kidney disease, Dialysis, Anemia, Division, Stanford University, Food, FDA, Pharmaceutical industry

Vafseo is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) developed by Akebia.

Key Points: 
  • Vafseo is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) developed by Akebia.
  • "As we continue to deliver on our promise for patients and public health, we are eager to closely collaborate with our partners to make this new oral treatment option available to patients."
  • Results from the INNO2VATE program were published in the New England Journal of Medicine: (N Engl J Med 2021; 384:1601-1612); (N Engl J Med 2021; 384:1589-1600).
  • See the Important Safety Information section below, including BOXED WARNING regarding increased risk of death, myocardial infarction, stroke, venous thromboembolism and thrombosis of vascular access.

Akebia Therapeutics to Report Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Monday, March 11, 2024
Chronic kidney disease, Dialysis, Anemia, Patient, Kidney disease, Akebia, Food, Vadadustat, AKBA, PDUFA

CAMBRIDGE, Mass., March 11, 2024 /PRNewswire/ -- Akebia Therapeutics ® , Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced plans to report fourth quarter and full year 2023 financial results on March 14, 2024.

Key Points: 
  • CAMBRIDGE, Mass., March 11, 2024 /PRNewswire/ -- Akebia Therapeutics ® , Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced plans to report fourth quarter and full year 2023 financial results on March 14, 2024.
  • Akebia will not host a conference call due to the proximity to the anticipated March 27, 2024 Prescription Drug User Fee Act (PDUFA) target action date for vadadustat, which is under review by the U.S. Food and Drug Administration as a treatment for anemia due to chronic kidney disease in adult patients on dialysis.

FibroGen/Astellas’ EVRENZO (roxadustat) Making In-Roads in European Market as In-Class Challenger, Akebia/Medice’s VAFSEO (vadadustat), Prepares for Launch in Early 2024.

Retrieved on: 
Friday, December 8, 2023
Akebia, Anemia, European Commission, Nephrology, Peritoneal dialysis, RealTime, GSK, Traction, Patient, Dialysis, History, CKD, Pharmaceutical industry

Meanwhile, GSK, the marketer of the sole approved HIF-PHI in the US, withdrew its application in July 2023, opting against introducing JESDUVROQ into the European market.

Key Points: 
  • Meanwhile, GSK, the marketer of the sole approved HIF-PHI in the US, withdrew its application in July 2023, opting against introducing JESDUVROQ into the European market.
  • Particularly in the German market, nearly all nephrologists report that they have already begun gaining clinical experience with EVRENZO, with notably high levels of satisfaction.
  • The utilization of EVRENZO among non-dialysis patients has grown across various stages, encompassing Stage 3, Stage 4, and Stage 5 patients.
  • Anticipation runs high for Akebia/Medice’s forthcoming VAFSEO in the dialysis sector, which is set for an official near-term launch in 2024.

Akebia Therapeutics to Present at Piper Sandler Healthcare Conference

Retrieved on: 
Monday, November 20, 2023
AKBA, EST, Kidney disease, Conference, Therapy, Piper Sandler Companies, Akebia

CAMBRIDGE, Mass., Nov. 20, 2023 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that John Butler, Chief Executive Officer, will participate in a fireside chat at the Piper Sandler 35th Annual Healthcare Conference on Tuesday, November 28th at 10:30 a.m. EST.

Key Points: 
  • CAMBRIDGE, Mass., Nov. 20, 2023 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that John Butler, Chief Executive Officer, will participate in a fireside chat at the Piper Sandler 35th Annual Healthcare Conference on Tuesday, November 28th at 10:30 a.m. EST.
  • The Piper Sandler Healthcare Conference will take place November 28 – November 30, 2023, in New York.
  • A webcast of the fireside chat can be accessed through the "Investors" section of Akebia's website at https://ir.akebia.com for approximately 90 days following the conference.

Akebia Therapeutics to Report Third Quarter 2023 Financial Results and Discuss Recent Business Highlights

Retrieved on: 
Tuesday, October 31, 2023
AKBA, Conference, Webcast, Cryptocurrency, Akebia

CAMBRIDGE, Mass., Oct. 31, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA) today announced plans to release its financial results for the third quarter ended September 30, 2023 on Wednesday, November 8, 2023, prior to the open of financial markets.

Key Points: 
  • ET
    CAMBRIDGE, Mass., Oct. 31, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA) today announced plans to release its financial results for the third quarter ended September 30, 2023 on Wednesday, November 8, 2023, prior to the open of financial markets.
  • Akebia will host a conference call on Wednesday, November 8 at 8:00 a.m.
  • ET to discuss its financial results and recent business highlights.
  • A live webcast of the conference call will be available via the Investors section of Akebia's website at: https://ir.akebia.com/ .

Akebia Receives FDA Acceptance of Resubmission to NDA of Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease

Retrieved on: 
Wednesday, October 25, 2023
FDA, PDUFA, Food, AKBA, Vadadustat, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Chronic kidney disease, Dialysis, New Drug Application, Kidney disease, Anemia, NDA, CKD, Patient, Pharmaceutical industry, Akebia

CAMBRIDGE, Mass., Oct. 25, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced the U.S. Food and Drug Administration (FDA) has acknowledged that the resubmission to its New Drug Application (NDA) for vadadustat as a treatment for anemia due to chronic kidney disease (CKD) in adult patients on dialysis, was complete. The FDA has classified this as a class 2 response, which results in a six-month review period from the date of resubmission, and the FDA set a user fee goal date ("PDUFA" date) of March 27, 2024.

Key Points: 
  • The FDA has classified this as a class 2 response, which results in a six-month review period from the date of resubmission, and the FDA set a user fee goal date ("PDUFA" date) of March 27, 2024.
  • "We're extremely pleased the FDA acknowledged our resubmission to our NDA for vadadustat was complete following our productive interactions over the past year.
  • We look forward to working closely with the agency to finalize the review," said John P. Butler, Chief Executive Officer of Akebia.
  • Akebia's resubmission to its NDA addressed the issues raised in the complete response letter.

Akebia Therapeutics Announces Five Poster Presentations at ASN Kidney Week 2023

Retrieved on: 
Wednesday, October 18, 2023
Patient, Burden, PDUFA, Food, Booth, ESKD, EST, AKBA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Poster, Society, Abstract (summary), Chronic kidney disease, Convention, National Primate Research Exhibition Hall, New Drug Application, Kidney disease, Anemia, Kidney, Pennsylvania Convention Center, Pharmaceutical industry, Akebia, Hyperphosphatemia, Dialysis

CAMBRIDGE, Mass., Oct. 18, 2023 /PRNewswire/ -- Akebia Therapeutics ® , Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that it will present data at the American Society of Nephrology Kidney Week 2023 (ASN Kidney Week), which will take place at the Pennsylvania Convention Center in Philadelphia from November 2-5, 2023.

Key Points: 
  • CAMBRIDGE, Mass., Oct. 18, 2023 /PRNewswire/ -- Akebia Therapeutics ® , Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that it will present data at the American Society of Nephrology Kidney Week 2023 (ASN Kidney Week), which will take place at the Pennsylvania Convention Center in Philadelphia from November 2-5, 2023.
  • Akebia-supported posters will be presented at ASN Kidney Week on November 2, 2023, from 10:00 a.m. – 12:00 p.m. EST.
  • ASN Kidney Week attendees can also visit Akebia at Booth #2515 in the Exhibit Hall.
  • Notably, Akebia will present a poster with data on alternate dosing for vadadustat, its investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for the treatment of anemia due to chronic kidney disease in adult patients on dialysis.

Akebia Therapeutics Resubmits New Drug Application to the FDA for Vadadustat

Retrieved on: 
Thursday, September 28, 2023
Chronic kidney disease, New Drug Application, NDA, AKBA, Dialysis, Patient, Anemia, PDUFA, FDA, Letter, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CKD, Vadadustat, Food, Kidney disease, Pharmaceutical industry, Akebia

Vadadustat is currently approved for use in 35 countries.

Key Points: 
  • Vadadustat is currently approved for use in 35 countries.
  • We look forward to working with the FDA during the review process and are eager to offer a new oral therapeutic to patients if approved."
  • Based on standard NDA resubmission review timelines, a letter from the FDA acknowledging that the resubmission is complete, classifying the resubmission, and setting the PDUFA date is expected in 30 days.
  • Akebia expects the FDA to set a PDUFA date of six months from the date of submission.

Akebia Therapeutics to Report Second Quarter Financial Results and Discuss Recent Business Highlights

Retrieved on: 
Wednesday, August 23, 2023
Webcast, AKBA, Therapy, Conference, Kidney disease, Akebia

CAMBRIDGE, Mass., Aug. 23, 2023 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced plans to release its financial results for the second quarter ended June 30, 2023 on Friday, August 25, 2023.  

Key Points: 
  • ET
    CAMBRIDGE, Mass., Aug. 23, 2023 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced plans to release its financial results for the second quarter ended June 30, 2023 on Friday, August 25, 2023.
  • Akebia will host a conference call on Friday, August 25, 2023 at 9:00 a.m.
  • ET to discuss its financial results and recent business highlights.
  • A live webcast of the conference call will be available via the Investors section of Akebia's website at: https://ir.akebia.com/ .

Akebia Therapeutics to Report Second Quarter Financial Results by August 25, 2023

Retrieved on: 
Thursday, August 17, 2023
Form, Calendar, AKBA, Therapy, Late, File, Kidney disease, Cryptocurrency, Akebia

CAMBRIDGE, Mass., Aug. 17, 2023 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced plans to release its financial results for the second quarter ended June 30, 2023 by Friday, August 25, 2023 prior to the open of the financial markets. Akebia will schedule a conference call in parallel with reporting its financial results.

Key Points: 
  • CAMBRIDGE, Mass., Aug. 17, 2023 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced plans to release its financial results for the second quarter ended June 30, 2023 by Friday, August 25, 2023 prior to the open of the financial markets.
  • Akebia will schedule a conference call in parallel with reporting its financial results.
  • On August 10, 2023, Akebia filed with the SEC a Form 12b-25 Notification of Late Filing regarding its Quarterly Report on Form 10Q (the Form 10Q) for the quarter ended June 30, 2023.
  • Akebia plans to file the Form 10-Q by August 25, 2023, and expects to regain compliance with the Nasdaq listing requirements upon filing.